Cleared Traditional

K972158 - GO MEDICAL PATIENT CONTROLLED ANALGESIA...

K972158 is an FDA 510(k) clearance for GO MEDICAL PATIENT CONTROLLED ANALGESIA..., manufactured by Princeton Regulatory Assoc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K972158 · Princeton Regulatory Assoc. · General Hospital
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Feb 1998
Decision
256d
Days
Class 2
Risk

K972158 is an FDA 510(k) clearance for the GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Princeton Regulatory Assoc. (Princeton, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 256 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Princeton Regulatory Assoc. devices

FDA 510(k) Submission Details - K972158

510(k) Number K972158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date February 20, 1998
Days to Decision 256 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 129d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MEB Pump, Infusion, Elastomeric

All 33
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K972158.
PAINBUSTER INFUSION KIT
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SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
K982102 · Baxter Healthcare Corp · Sep 1998
PAINBUSTER INFUSION SYSTEM
K980558 · I-Flow Corp. · May 1998
MEDI-SIS SYRINGE INFUSION SYSTEM
K972173 · I-Flow Corp. · Aug 1997
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · Baxter Healthcare Corp · Jul 1997
BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
K955727 · I-Flow Corp. · Feb 1996